Prescription drug · ANDA
Voriconazole NDC 43547-378
Voriconazole 200 mg/1 · Tablet, Coated · Oral · Solco Healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-378-03 | 4354703780343547037803 | 30 TABLET, COATED in 1 BOTTLE (43547-378-03)Marketed from Oct 28, 2016 | |
| 43547-378-50 | 4354703785043547037850 | 500 TABLET, COATED in 1 BOTTLE (43547-378-50)Marketed from Oct 28, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Voriconazole
- Generic name (nonproprietary)
- voriconazole
- Active ingredients
- Voriconazole — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Solco Healthcare U.S., LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206654
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-378_ba05ccd8-a545-4f7a-b343-b8b207080b79SPL ID ba05ccd8-a545-4f7a-b343-b8b207080b79SPL set ID f6a1a792-141b-42e8-8bd1-884e4408eb8aRxCUI 349434, 349435UNII JFU09I87TRUPC 0343547377038, 0343547378035
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443547037803followed by a unit qualifier and the quantityPackage 43547-0378-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Voriconazole tablets are azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: • Invasive aspergillosis ( 1.1 ) • Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) • Esophageal candidiasis ( 1.3 ) • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 ) 1.1 Invasive Aspergillosis Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergi…
Excerpt only. Read the full label for complete information.
About NDC 43547-378
- What is NDC 43547-378?
- 43547-378 is the product NDC for Voriconazole, Voriconazole 200 mg/1 tablet, coated, listed with the FDA by Solco Healthcare U.S., LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Voriconazole.
- What is the active ingredient?
- Voriconazole.
- Who is the labeler?
- Solco Healthcare U.S., LLC, NDC labeler code 43547. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Voriconazole?
- 52 other product NDCs are listed under this name. See all Voriconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Voriconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-968 | 60687-0968-21 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-979 | 60687-0979-21 |
| Voriconazolevoriconazole injection | Voriconazole 10 mg/mL | InjectionIntravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1091 | 00121-1091-55 |
| Voriconazole | Voriconazole 50 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-146 | 48433-0146-03 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-147 | 48433-0147-03 |
| Voriconazole | Voriconazole 10 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-730 | 14335-0730-10 |
| Voriconazole | Voriconazole 40 mg/mL | Powder, For suspensionOral | Camber Pharmaceuticals, Inc. | 31722-266 | 31722-0266-31 |
| voriconazole | Voriconazole 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1198 | 72162-1198-03 |
| voriconazole | Voriconazole 40 mg/mL | Powder, For suspensionOral | Zhejiang Poly Pharm Co., Ltd. | 72673-111 | 72673-0111-30 |
| Voriconazole | Voriconazole 10 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Camber Pharmaceuticals, Inc. | 31722-224 | 31722-0224-31 |
Other NDCs under ANDA 206654
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Voriconazole | Voriconazole 50 mg/1 | Tablet, CoatedOral | Solco Healthcare U.S., LLC | 43547-377 |
| Voriconazole | Voriconazole 200 mg/1 | Tablet, CoatedOral | AvPAK | 50268-803 |